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About
This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.
20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:
Full description
Although global initiatives have made great strides in controlling the human immunodeficiency virus (HIV) pandemic, HIV and acquired immune deficiency syndrome (AIDS) continue to impact the lives and livelihoods of a significant portion of the population. In 2019, 38 million individuals were living with HIV and 690,000 died of AIDS-related causes. Despite extensive global efforts for disease control over the last 20 years, 1.7 million individuals contract HIV annually. Antiretroviral therapy (ART) reduces morbidity and mortality associated with HIV by suppressing viral replication but does not eradicate infection. There are barriers to universal ART use that include toxicities, costs, drug resistance, and the need for lifelong adherence. To overcome these barriers, HIV broadly neutralizing antibodies (bNAbs) represent a novel approach to HIV prevention and treatment.
The primary endpoint of change in viral load will be assessed at day 14. Participants will then transition to Step 2, during which all participants will take standard daily oral ART and have viral load monitored through Step 2 week 48.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Able to read and write in Kiswahili and/or English
Able and willing to provide written informed consent
Passes Test of Understanding (TOU)
Aged 18-50 years, inclusive
Antiretroviral Therapy (ART)-naïve or no ART for > 24 weeks at the time of screening
HIV RNA 1,000-100,000 copies/mL
CD4 ≥ 500 cells/mm3
Laboratory criteria at screening within protocol-specified limits for blood, chemistry and urinalysis
Willing and able to participate in study visits and procedures for up to 50 weeks
Willing and able to begin ART as directed during the study
Willing and able to use barrier protection during sex with partners without HIV or partners with unknown HIV status throughout Step 1 and until viral suppression <200 copies/mL is confirmed in Step 2
Willing and able to adhere to the following contraception requirements:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 5 patient groups
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Central trial contact
David D. Ho, MD; Magdalena Sobieszczyk, MD
Data sourced from clinicaltrials.gov
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